Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Official Title ICMJE

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

Brief Summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.

After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.

Other Names:

Byetta

AC2993

synthetic exendin-4

Drug: Placebo

After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.

Study Arm (s)

Experimental: Exenatide

After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen

Intervention: Drug: exenatide

Placebo Comparator: Placebo

After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

182

Completion Date

August 2005

Primary Completion Date

August 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.

HbA1c between 7.1% and 10.0%, inclusive.

Body mass index (BMI) between 25 kg/m^2 and 45 kg/m^2.

Exclusion Criteria:

Patient previously in a study using exenatide or GLP-1 analogs.

Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.

Treated with oral insulin within 3 months of screening.

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects